# China NMPA Product Recall - Intra-aortic balloon counterpulsation pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/arrow-international-inc/7d523844-72b8-4a8e-8e6e-8bc4cc7d651f/
Source feed: China

> China NMPA product recall for Intra-aortic balloon counterpulsation pump by Arrow International Inc. published May 05, 2023. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) has announced an expanded recall initiated by Ar

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Arrow International LLC expands active recall of intra-aortic balloon counterpulsation pumps.
- Company Name: Arrow International Inc.
- Publication Date: 2023-05-05
- Product Name: Intra-aortic balloon counterpulsation pump
- Recall Level: Level 1 Recall
- Recall Reason: Equipment runtime is shortened in emergency battery power supply mode
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Arrow International Inc.
- Summary: The National Medical Products Administration (NMPA) has announced an expanded recall initiated by Arrow International LLC concerning its intra-aortic balloon counterpulsation pumps. This action, reported by Telefel Medical Devices Trading (Shanghai) Co., Ltd., on May 5, 2023, stems from a critical safety issue: the devices experience shortened operating time when relying on emergency battery power. This condition poses a significant risk to patients requiring life support, as it compromises the essential functionality of these critical medical devices during crucial periods. Arrow International LLC first initiated a voluntary recall in 2022 due to this issue, and the current announcement signifies an expansion of that earlier recall. The NMPA has classified this as a Level 1 Recall, indicating the highest level of severity and potential for serious adverse health consequences or death. While specific inspection dates are not mentioned in the provided text, the recall highlights the manufacturer's responsibility under NMPA regulations to address serious product deficiencies promptly. The company is required to manage and communicate details of the affected models, specifications, and batches, as outlined in the "Medical Device Recall Event Report Form," to ensure all impacted units are identified and removed from circulation or appropriately remedied. This expanded recall underscores a commitment to patient safety and regulatory compliance within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/arrow-international-inc/8820e141-5ce7-4e2d-844a-672ff4232c9c/